MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; HEATED BREATHING TUBE

Model Number	900PT561
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product background: the heated breathing tube (hbt) is a component designed for use with the airvo humidification series, for the delivery of humidified respiratory gases to patients, including those who are receiving nasal high flow (nhf) therapy.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The hbt as part of the airvo system contains a heater wire encapsulated in plastic which ensures optimal temperature and humidification levels are delivered to the patient interface while minimising the amount of condensate in the tube.Method: the subject hbt as part of the 900pt561 heated breathing tube and chamber kit was not returned to fisher & paykel healthcare (f&p) for evaluation.F&p's investigation is based on the information and photograph provided by the distributor, previous investigations of similar complaints, and f&p's knowledge of the product.Results: visual inspection of the photograph provided by the distributor confirmed that the subject hbt was melted.The subject hbt was observed to have adhered to a blanket and had partially unravelled, exposing the heater wire.The distributor reported that the airvo 2 unit used with the subject heated breathing tube was not shut down and the subject heated breathing tube had been covered with a blanket during the reported event, causing the tube to melt.The distributor reported that the device was not in use by the patient at the time of the reported event as the patient had left the ward midway through receiving therapy.There was no patient involvement as the issue was found whilst the device was not in use on a patient.Conclusion: f&p's investigation has determined that the damage to the subject hbt as part of the 900pt561 heated breathing tube and chamber kit was caused by the subject hbt being covered for a prolonged period.The distributor reported that the subject heated breathing tube had been covered with a blanket during the reported event, causing the tube to melt.The 900pt561 user instructions show in pictorial format the correct placement of the device and includes the following information: "do not add heat to any part of the breathing tube e.G., covering with a blanket, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." "connect breathing tube clip to patient clothing or bedding." "never operate the unit if the breathing tube has been damaged with holes, tears or kinks" "do not block the flow of air through the unit and breathing tube." "do not allow the breathing tube to remain in direct contact with skin for prolonged periods of time." all hbts as part of the 900pt561 are visually inspected and undergo functional tests, including soak and temperature, and heater wire resistance.The hbts are 100% visually inspected using a camera system.The hbts are also tested for resistance, continuity, polarity and pitch during production.Additionally, a functional test is conducted under load.The subject hbt would have met the required specifications at the time of production.The airvo system is designed to comply with the electrical safety standard iec 60601-1: 2005+a1:2012.The case is composed of a flame retardant material.The surface temperature of the hbt, when used in accordance with user instructions, is designed to be within the limits specified by iso 8185 with regard to hot tube surface temperature not exceeding 44° celsius.It is an inherent risk of hbts, that additional heat (above ambient levels) added to any part of the tube via an external source or being covered with material, may lead to the tubing becoming damaged.To address this inherent risk and as is required under iso 80601, the user instructions for the 900pt561 contains the warning "do not add heat to any part of the breathing tube e.G.Covering with a blanket, or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury." additional "do not cover" tags are also attached to all hbts to alert the user that the hbt should not be covered.There are many safety features incorporated into the airvo system to prevent overheating and fire.These include: the heater wires in the hbt are completely insulated from the gas path.The pcb at the user end of the hbt is over moulded with the thermoplastic polymer polypropylene, ensuring it is excluded from the gas path.The airvo device contains technology which detects short circuits and transient current events in the hbt.When detected, the airvo removes power to the hbt.The airvo performs this detection at any time it is turned on and connected to the hbt.This functionality is checked by the control system each time the airvo is powered up, or when a new hbt is connected.An 'over-temperature' sensor will automatically cut power to the motor, heater plate and heater wire if it detects any overheating at the chamber or the patient end of the hbt.The airvo device continuously checks power in the hbt and disables the heater wire if the measured power is too high.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china via a fisher and paykel healthcare (f&p) field representative that the heated breathing tube as part of the 900pt561 heated breathing tube and chamber kit was found melted.The distributor reported that the device was not in use by the patient at the time of the reported event as the patient had left the ward midway through receiving therapy.The distributor further reported that the airvo 2 unit used with the subject heated breathing tube was not shut down and the subject heated breathing tube had been covered with a blanket during the reported event, causing the tube to melt.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: HEATED BREATHING TUBE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23752990
• Report Number: 9611451-2025-01925
• Device Sequence Number: 5854582
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2103779424(11)250520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: 2103779424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: F&P OPT944 OPTIFLOW + NASAL CANNULA.; F&P PT101 AIRVO 2 HUMIDIFIER.
• Patient Sex: Unknown